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Food and Drug Administration

Joint meeting of the
Nonprescription Drugs Advisory Committee
and the
Endocrinologic and Metabolic Drugs Advisory Committee

January 23, 2006

The committees will consider the safety and efficacy of newdrug application (NDA) 21-887, proposing
over-the-counter (OTC) use of ORLISTAT (tetrahydrolipstatin) capsules (60 milligrams (mg)),
GlaxoSmithKline Consumer Healthcare, L.P., to promote weight loss in overweight adults when used along with a reduced calorie and low fat diet.

Briefing Information

GlaxoSmithKline Consumer Health Care, L.P.


The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not
necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or
effectiveness of the product described in this document.

Orlistat 60mg Capsules Briefing Document



Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act
(the FOIA) (5 U.S.C. 552). These redacted portions will appear as white space on the screen or on the printed page.

FDA Backgrounder Table of Contents


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